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Evaluation of a Diabetes Data Management System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00694070
First received: June 6, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
Results First Received: July 1, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: Diabetes

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users

Participant Flow:   Overall Study
    Health Care Professionals and Lay Users  
STARTED     51  
COMPLETED     51  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users

Baseline Measures
    Health Care Professionals and Lay Users  
Number of Participants  
[units: participants]
 		  51  
Age  
[units: years]
Median ( Full Range ) 		  53  
  ( 18 to 82 )  
Gender  
[units: participants]
 		 
Female     29  
Male     22  



  Outcome Measures
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1.  Primary:   Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)   [ Time Frame: 1-2 hours ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Rated as <= 3 (Success in Using the Program)   [ Time Frame: 1-2 hours ]
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Measure Type Primary
Measure Title Number of Participants Rated as <= 3 (Success in Using the Program)
Measure Description

Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:

  1. successful
  2. successful after being referred to user instructions
  3. success with assistance (similar to a customer call)
  4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.
Time Frame 1-2 hours  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Health Care Professionals and Lay Users h= 8 health care professionals p= 43 lay users

Measured Values
    Health Care Professionals and Lay Users  
Number of Participants Analyzed  
[units: participants]
 		  51  
Number of Participants Rated as <= 3 (Success in Using the Program)  
[units: Participants]
 		  50  


Statistical Analysis 1 for Number of Participants Rated as <= 3 (Success in Using the Program)
Groups [1] Health Care Professionals and Lay Users
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Exact binomial test
P Value [4] 0.0309
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
 

The null and alternative hypotheses for these tests will have the form:

Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%.
[3] Other relevant information, such as adjustments or degrees of freedom:
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[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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3.  Primary:   Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)   [ Time Frame: 1-2 hours ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Clinical Research Scientist
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3063


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00694070     History of Changes
Other Study ID Numbers: CTD-2008-11
Study First Received: June 6, 2008
Results First Received: July 1, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board